Governmental Decree No. HG483/2020 validating General Procedure of registration of food additives, food ensymes and food flavorings.

This Governmental Decree establishes a general procedure for the assessment and registration of food additives, food enzymes, food flavorings and food raw materials for flavorings and food ingredients with flavoring properties used or intended for use in in foodstuffs. The general procedure promotes the free movement of food inside the country and procedural measures to update the list of substances that are authorized for sale in order to ensure effective functioning of the internal market, a high level of protection of public health and a high level of consumer protection, including the protection of consumer interests and good practice in the food trade. In order to update national lists, it is necessary to ensure that the use of the substance complies with the general and specific conditions of use as stipulated in the specified normative acts. This General Procedure sets out the stages, the timing of the respective stages, the role of the parties involved and the principles to be applied, provides for measures to implement content, method of drafting and submitting requests for updating national lists according to each food regulation, methods of checking the validity of requests and the type of information. The main steps in the general procedure shall be as follows: (a) the general procedure for updating the national list can be initiated by the National Agency for Public Health or by request. Requests can be submitted by an interested party who can represent multiple stakeholders; (b) the general procedure ends with the adoption by the Ministry of Labor, Health and Social Protection of the provisions on the implementation of the list update; and (c) by way of derogation from subparagraph 2), the Agency may terminate the general procedures and decide not to carry out the planned update at any stage of the procedures if it considers that such an update is not warranted. In such situations the Agency informs the applicant directly, indicating in its letter the reasons why the update is not considered justified.